Bristol-AstraZeneca Diabetes Drug Wins U.S. FDA Approval

By Anna Edney -
Jan 8, 2014

A diabetes pill from Bristol-Myers
Squibb Co. (BMY) and AstraZeneca Plc won U.S. approval, becoming the
second in a new class of medicines to treat the disease.

The Food and Drug Administration cleared the drug, known as
dapagliflozin, according to a statement from the agency today.
The FDA had rejected the Type 2 diabetes treatment, to be called
Farxiga, in 2012 after advisers raised concern about the bladder
and breast cancer risk. Additional data downplayed the potential
harm and advisers backed the pill in December.

Johnson & Johnson gained clearance in March to sell
Invokana, the first in a class of therapies called SGLT2
inhibitors that includes dapagliflozin. The New York-based
Bristol-Myers and London-based AstraZeneca drug, approved in
Europe in 2012, may generate $160 million in sales this year for
AstraZeneca, rising to $1.5 billion in 2020, Seamus Fernandez,
an analyst with Leerink Partners has estimated.

Bristol-Myers is selling its share of the diabetes alliance
it has with AstraZeneca for as much as $4.3 billion. The
partnership includes dapagliflozin, Onglyza, Byetta and
Bydureon, Bristol-Myers said in a Dec. 19 statement.

Diabetes is the seventh-leading cause of death in the U.S.,
according to the Centers for Disease Control and Prevention. The
disease, defined by high levels of sugar in the blood, affected
almost 26 million people in the U.S. in 2010, or about 8.3
percent of the population, the CDC said.